NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE 216703

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-25 for NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE 216703 manufactured by Aspen Surgical Products, Caledonia.

MAUDE Entry Details

Report Number1836161-2019-00096
MDR Report Key9370627
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-25
Date of Report2019-10-29
Date of Event2019-10-17
Date Mfgr Received2019-10-29
Date Added to Maude2019-11-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JORDAN HACKERT
Manufacturer Street6945 SOUTHBELT DR. S.E.
Manufacturer CityCALEDONIA MI 49316
Manufacturer CountryUS
Manufacturer Postal49316
Manufacturer Phone6165367508
Manufacturer G1SAME AS ABOVE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.535 STERILE
Generic NameSURGICAL NEEDLE
Product CodeGAB
Date Received2019-11-25
Model Number216703
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer Address6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-11-25

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